Consumer Representative Is Lone Voice Against Approving TOBI Podhaler
Rodney Mullins, national director of Public Health Consultants and Advocates, cast the lone vote on FDA’s Anti-Infective Drugs Advisory Committee against approving Novartis’ TOBI Podhaler for the management of cystic fibrosis patients infected with Pseudomonas aeruginosa.
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Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.
FDA’s Anti-Infective Drugs Advisory Committee was fully satisfied with “sputum culture conversion” as a surrogate endpoint for accelerated approval, but turned back a last-minute question from FDA on traditional full approval for the tuberculosis drug bedaquiline.